MODDERN Cures Act of 2013 2013-09-12 Introduced in House Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2013 or MODDERN Cures Act of 2013 - Requires the Secretary of Health and Human Services (HHS) to: (1) establish the Advanced Diagnostics Education Council to recommend standard terms and definitions related to innovative diagnostics for use by patients, physicians, health care providers, payers, and policy makers; and (2) publish a guide regarding such terms and definitions.

Sets forth additional factors for the Secretary to consider in determining the payment amount for new clinical diagnostic laboratory tests under gap filling procedures which are used when no comparable existing test is available.

Extends the exclusivity period for a medicine if the diagnostic test related to such drug has been determined by the Secretary to have been developed by, or with the participation of, the manufacturer or sponsor of the medicine, and use of the diagnostic tests provides for or improves: (1) the identification of a patient population for the medicine; or (2) the determination of the most appropriate treatment option for a patient population with the medicine.

Establishes a dormant therapy designation for medicine that addresses unmet medical needs. Gives such medicine 15 years of data exclusivity under which no drug can be approved by relying on the approval or licensure of the dormant therapy.

Directs the Secretary to arrange with the Institute of Medicine (or, if it declines, another appropriate entity) to study intellectual property laws and their impact on therapy and diagnostic development in order to formulate recommendations on how to facilitate the clinical evaluation and development of therapies currently available on the market for new potential indications.]]>

text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.